jRCT2021240015招募中不适用
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MSD K.K.
- 入组人数
- 71
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Histologically or cytologically confirmed diagnosis of squamous squamous non-small cell lung cancer (NSCLC) [Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8]
- •2.Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
- •3.Has life expectancy >=3 months
- •4.Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
- •5.Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
- •6.Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •7.Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
- •8.Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- •9.Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to <= Grade 1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)
- •10.Has adequate organ function
- •11.For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12
- •12.For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
- •13.For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade <=2 endocrine-related AEs requiring treatment or hormone replacement) have recovered
- •14.For Maintenance only (prior to randomization): has adequate organ function
排除标准
- •1.Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- •2.Grade >=2 peripheral neuropathy
- •3.History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- •4.Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- •5.Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
- •6.HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •7.Received prior systemic anticancer therapy for their metastatic NSCLC
- •8.Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic Tlymphocyte-associated protein 4, OX-40, CD137) [Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.]
- •9.Received prior treatment with a TROP2-targeted antidrug conjugate (ADC)
- •10.Received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation
- •11.Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
- •12.Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- •13.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- •14.Participants who have not adequately recovered from major surgery or have ongoing surgical complications
- •15.Received prior treatment with a topoisomerase I inhibitor-containing ADC
- •16.Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
- •17.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •18.Has known CNS metastases/carcinomatous meningitis (participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Subjects with known untreated, asymptomatic brain metastases [ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm] may participate but will require regular imaging of the brain as a site of disease)
- •19.Severe hypersensitivity (>=Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
- •20.Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy [eg, thyroxine, insulin, or physiologic corticosteroid] is allowed)
- •21.History of (noninfectious)pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •22.Active infection requiring systemic therapy
- •23.History of allogeneic tissue/solid organ transplant
结局指标
主要结局
-
1.Overall survival (OS)
次要结局
- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)(Baseline to a Predefined Timepoint)
- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)(Baseline to a Predefined Timepoint)
- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)(Baseline to a Predefined Timepoint)
- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)(Baseline to a Predefined Timepoint)
- Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30)
- TTD in Dyspnea Score (EORTC QLQ-C30 Item 8)
- TTD in Cough (EORTC QLQ-LC13 Item 31)
- TTD in Chest Pain (EORTC QLQ-LC13 Item 40)
研究者
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